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R46778

The Generic Drug User Fee Amendments (GDUFA): Background and Reauthorization

Published Apr 29, 2021Updated Jun 21, 2025

The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.

The Generic Drug User Fee Amendments (GDUFA): Background and Reauthorization — Informed